Expect clarity, compliance, and quality. Expect more.
We believe that the quality of documentation can influence the flow of a clinical study. That’s why we are dedicated to providing you with the documents you need to support your drug’s development journey with confidence. Our medical writers provide you with documents written with clarity in the languages you require and compliant with all ICH guidelines and regulatory requirements. They are experienced in writing for key therapeutic areas covering all phases of clinical development, including real-world evidence.
The global medical writing team is made up of professionals, including MDs and others with advanced training in health science, such as biomedics and biologists. As quality EMA- and FDA-compliant documentation writing is imperative to us, they were chosen because of their strong research background, excellent language skills, and knowledge of biostatistics. Many are members of the European Medical Writers Association (EMWA).
Our writers tend to work with us for years, which enables us to provide continuity and experience to our customers. Half of our medical writers have more than ten years of experience.
For us, experience means efficiency, and clinical trials are incredibly time-sensitive. Usually, you can expect the first drafts of protocol and CSR in four to five weeks. Further versions can be delivered within five and ten working days after receiving your comments.
Throughout the trial, TFS medical writers cooperate closely with other teams involved in the study so you can expect clarity, accuracy, and compliance in every document.
TFS medical writers can help you translate complex data and concepts into messages that people can understand.
Assistance with publication submission (article, abstract, poster, etc.), pre-submission scientific editing, English language review, statistical review, and revision of manuscript in response to peer review comments
We take pride in our documents being accepted by our clients for submission-ready issues or health authority validation issues.